Position: Manufacturing Associate I/II

This position is immediately available to join our Manufacturing team to perform cGMP manufacturing to support Capricor’s clinical trials and exosome development. We are seeking an individual with a scientific background, mammalian cell culture and cGMP experience.

Responsibilities:

• Conducting routine manufacturing of biologic products including media preparation, cell culture, cell counting, formulation, centrifugation and freezing
• Independently completing required documentation and guiding other operators on proper cGMP recording of entries and comments on batch records, forms and protocols
• Compiling data for documentation of test procedures and reporting abnormalities
• Making detailed observations, planning and assisting with data collection, data analysis, writing and disseminating production results
• Authoring, revising and updating standard operating procedures using the document change system
• Maintaining broad knowledge of state-of-the-art principles and theories
• Maintaining inventory, material transfers and cleanroom-required activities to support cGMP operations
• Preparing technical summaries, protocols and reports
• Initiating and closing deviations, investigations and CAPAs of moderate complexity; and
• Performing special manufacturing and development projects

Requirements:

• Bachelor’s degree in Biomedical Engineering, Biological Sciences or related field
• 1-3 years of experience in cGMP/cGTP manufacturing environment in academic/industry setting
• Laboratory experience in mammalian tissue culture is required
• Working knowledge of the regulatory requirements (cGMP/cGTP) in the biopharmaceutical, blood and / or tissue banking industry
• Exceptional communication and interpersonal skills
• Excellent organizational skills and attention to detail
• Ability to work in a dynamic environment
• Basic molecular biological and flow cytometry skills are preferred
• Adaptable/flexible with work schedule with an ability to multi-task and prioritize work
• From time-to-time extended hours may be required with or without notice, dependent on the work needed

Work Environment/Physical Demands:

• Must be able to sit and stand for extended periods.
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork.
• Able to fully gown and work in a manufacturing area.
• Work extended or off hours depending on the company needs to respond to manufacturing schedule (including weekends, holidays), as required

Looking for more jobs near me. Find your favorite job now by visiting our jobs page.